Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
研究概览
简要总结
This is a multicenter, open-label, single-arm, prospective Phase II clinical trial. The study enrolls patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma who have undergone curative resection and harbor high-risk recurrence factors, including: 1) narrow resection margin (including R1 resection); 2) positive circumferential resection margin; 3) T stage ≥ T3-4; 4）positive regional lymph nodes. All patients will receive postoperative concurrent chemoradiotherapy (CCRT) with intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). The high-risk volumes of the primary tumor bed and metastatic lymph node beds will be irradiated to 48-60 Gy in 20-25 fractions. Retroperitoneal and intra-abdominal lymph nodes will receive 50-57.5 Gy in 20-25 fractions, and lymphatic drainage regions will be treated to 40-45 Gy in 20-25 fractions. During radiotherapy, concurrent oral capecitabine will be administered at a dose of 1,600 mg/m² on Days 1-14, every 21 days for 2 cycles. Following the completion of radiotherapy, maintenance oral capecitabine will be continued at 2,000 mg/m² on Days 1-14, every 21 days for 6 cycles. For patients intolerant to capecitabine, S-1 will be substituted: concurrent S-1 40-50 mg twice daily on Days 1-28, every 42 days for 1 cycle, followed by maintenance S-1 40-60 mg twice daily on Days 1-28, every 42 days for 3 cycles.
The primary study endpoint is the 2-year recurrence-free survival (RFS) rate. Secondary study endpoints include the 2-year overall survival (OS) rate, locoregional control rate, and incidence of grade ≥3 adverse events.
A total of 92 patients are planned for enrollment in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years
- •Underwent curative resection for newly diagnosed disease, with postoperative pathology confirming extrahepatic cholangiocarcinoma or gallbladder adenocarcinoma
- •Postoperative pathology with ≥1 high-risk factor for recurrence
- •Narrow resection margin (<1 cm), including R1 resection
- •Positive circumferential resection margin
- •T stage ≥ T3-4
- •Positive regional lymph nodes
- •Postoperative liver function: Child-Pugh grade A5-B7
- •No recurrence or metastasis before postoperative radiotherapy
- •ECOG performance status 0-2
- •Expected survival >3 months
- •Routine blood tests: Neutrophils ≥1.0×10⁹/L, hemoglobin ≥80 g/L, platelets ≥100×10⁹/L
- •Liver function: Total bilirubin <1.5×upper limit of normal (ULN), plus one of the following:
- •ALT and AST ≤2.5×ULN
- •ALT ≤1.5×ULN and AST ≤6×ULN (excluding AST elevation due to myocardial infarction)
- •Renal function: Creatinine and blood urea nitrogen ≤2.5×ULN
- •Voluntary participation and signed informed consent
排除标准
- •History of other malignant tumors (except papillary thyroid carcinoma, basal cell carcinoma of the skin, and cervical carcinoma in situ)
- •Severe comorbidities (e.g., myocardial infarction, arrhythmia, psychiatric disorders)
- •Prior abdominal radiotherapy
- •Post-organ transplantation
- •Symptomatic moderate-severe ascites within 4 months postoperatively
- •≥4 months since surgery
研究组 & 干预措施
Postoperative Concurrent Chemoradiotherapy Group
干预措施: Postoperative radiotherapy (Radiation)
Postoperative Concurrent Chemoradiotherapy Group
干预措施: Capecitabine or S-1 (Drug)
研究者
BO CHEN
Associate Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences